The U.S. Food and Drug Administration (FDA) has granted approval for Grifols’ new product, fibrinogen, human-chmt (Fesilty), aimed at treating acute bleeding episodes in patients with congenital fibrinogen deficiency (CFD). This condition, which includes hypo- or afibrinogenemia, affects individuals from birth due to genetic mutations that impair fibrinogen production or function. Grifols announced this development in a press release dated December 19, 2025, highlighting that the treatment is expected to be available in the United States during the first half of 2026.
Roland Wandeler, President of Grifols Biopharma, expressed enthusiasm about the approval, stating, “With the approval of [fibrinogen, human-chmt], we are excited to be able to provide U.S. health care providers and patients with CFD a safe, effective and reliable treatment for acute bleeding episodes – when every minute counts.” This approval marks a significant advancement in Grifols’ mission to expand access to vital medicines globally.
Congenital fibrinogen deficiency is characterized by insufficient levels of fibrinogen, a plasma protein essential for blood clotting and wound healing. Patients with low fibrinogen levels face challenges in effectively controlling bleeding, particularly during acute events. Traditional treatment options, such as fresh frozen plasma and cryoprecipitate, may require large volumes and introduce additional proteins that are unnecessary for fibrinogen replacement.
Grifols’ fibrinogen, human-chmt is specifically designed as a human blood coagulation factor for treating acute bleeding episodes in both pediatric and adult patients with CFD. The product is manufactured at the “Biotest Next Level” facility located in Dreieich, Germany. Notably, the United States is the second country to approve this fibrinogen concentrate, following Germany, where it is marketed under the name Prufibry.
Approval for this treatment was based on results from a clinical study titled “A Prospective, Open-label, Phase I/III Study Investigating Pharmacokinetic Properties of BT524 and Efficacy and Safety of BT524 in the Treatment and Prophylaxis of Bleeding in Patients With Congenital Fibrinogen Deficiency.” The study indicated that the most serious adverse reactions associated with fibrinogen, human-chmt included thrombotic events—such as portal vein thrombosis and deep vein thrombosis. One patient experienced an episode of epilepsy leading to death due to an extradural hematoma four weeks after administration.
In the clinical study, adverse reactions occurring in more than 2% of patients included pain in extremity, back pain, hypersensitivity reactions, fever, thrombosis, increased fibrin D dimer levels, headache, and vomiting. Grifols anticipates that the product will be accessible to healthcare providers and patients during the first half of 2026, offering a new option for managing an often challenging and rare condition.
As Grifols prepares for the launch of fibrinogen, human-chmt, its commitment to improving healthcare for patients with congenital fibrinogen deficiency continues to unfold, promising a more reliable treatment pathway for those affected by this rare but serious condition.
